BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM

    MDR report key: 23550328 · Received November 13, 2025

    Report

    Report Number
    3021325287-2025-00052
    Event Type
    Injury
    Date Received
    November 13, 2025
    Date of Event
    October 27, 2025
    Report Date
    November 13, 2025
    Manufacturer
    NOAH MEDICAL CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K223144
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SYSTEM AND BRONCHOSCOPE MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ISSUES ASSOCIATED WITH THIS CASE. THE SCOPE WAS NOT RETURNED FOR INVESTIGATION, AS IT WAS DISCARDED. MANUFACTURING RECORDS CONFIRMED THE SCOPE PASSED FINAL QA/QC TESTING. VIDEO REVIEW IDENTIFIED NO SYSTEM MALFUNCTIONS BUT OBSERVED A USE ERROR IN WHICH THE BIOPSY TOOL WAS EXTENDED BEYOND THE AF CIRCLE MULTIPLE TIMES, RESULTING IN MINOR BLEEDING. NO SIGNS OF PNEUMOTHORAX WERE OBSERVED DURING THE PROCEDURE. THE PHYSICIAN DID NOT ATTRIBUTE THE PNEUMOTHORAX TO THE GALAXY SYSTEM, STATING IT WAS DUE TO OVERLY AGGRESSIVE BAL FLUID ADMINISTRATION. BASED ON AVAILABLE INFORMATION, THE INJURY IS CONSISTENT WITH THE KNOWN INHERENT RISKS OF BRONCHOSCOPY, PARTICULARLY WHEN EXTENSIVE LAVAGE OR DEEP TISSUE MANIPULATION IS PERFORMED. THIS COMPLAINT IS REPORTED DUE TO THE FOLLOWING CONCLUSIONS: A PNEUMOTHORAX WAS REPORTED AFTER A GALAXY-ASSISTED BIOPSY PROCEDURE. THE PNEUMOTHORAX WAS IDENTIFIED ON A POST-PROCEDURE X-RAY, PROMPTING IMMEDIATE CHEST TUBE INSERTION AND HOSPITAL ADMISSION. THE PHYSICIAN DID NOT ATTRIBUTE THE PNEUMOTHORAX TO THE GALAXY SYSTEM, STATING IT WAS DUE TO OVERLY AGGRESSIVE BAL (BRONCHOALVEOLAR LAVAGE) FLUID ADMINISTRATION. NO MALFUNCTIONS WERE REPORTED AND A USE ERROR WAS IDENTIFIED.

    Description of Event or Problem · 0

    A PNEUMOTHORAX WAS REPORTED AFTER A GALAXY-ASSISTED BIOPSY PROCEDURE. THE PNEUMOTHORAX WAS IDENTIFIED ON A POST-PROCEDURE X-RAY, PROMPTING IMMEDIATE CHEST TUBE INSERTION AND HOSPITAL ADMISSION. THE PATIENT WAS SUBSEQUENTLY DISCHARGED IN STABLE CONDITION. THE PHYSICIAN DID NOT ATTRIBUTE THE PNEUMOTHORAX TO THE GALAXY SYSTEM, STATING IT WAS DUE TO OVERLY AGGRESSIVE BAL (BRONCHOALVEOLAR LAVAGE) FLUID ADMINISTRATION. NO MALFUNCTIONS WERE REPORTED AND A USE ERROR WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2140022 GALAXY SYSTEM GALAXY SYSTEM EOQ NOAH MEDICAL CORP. GALB-001 6025030512

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H